Lupin Announces FDA Approval of Supplemental New Drug Application for SOLOSEC? (secnidazole) for the Treatment of Trichomoniasis
BALTIMORE, July 1, 2021?? Lupin Pharmaceuticals, Inc. (Lupin), announced today that the U.S. Food and Drug Administration (FDA) has approved the Company?s supplemental New Drug Application to expand the use of SOLOSEC? (secnidazole) to include the treatment of trichomoniasis in adults. Trichomoniasis is the most common non-viral, curable sexually transmitted infection (STI) in the U.S., affecting an estimated three to five million people every year.1?SOLOSEC? was approved in the U.S. in 2017 for the treatment of bacterial vaginosis (BV) in adult women. The supplemental approval makes SOLOSEC? the first and only single-dose oral prescription antimicrobial agent approved for the treatment of both trichomoniasis and BV.
?The FDA?s approval for the additional indication for SOLOSEC? to treat trichomoniasis builds upon our commitment to support women?s health and provides health care professionals with an option to treat patients with trichomoniasis and bacterial vaginosis (BV), which research demonstrates that approximately 70% of women with trichomoniasis are PCR positive for BV,2? said?Jon Stelzmiller,?President ? Specialty, Lupin Pharmaceuticals, Inc. He also stated, ?Additionally, having a treatment option for both trichomoniasis and BV that provides a complete course of therapy in a single dose will help address gaps in care related to adherence,3?and therefore, may reduce risk factors associated with trichomoniasis or BV,4,5?such as pelvic inflammatory disease (PID)6,7,8?and other STIs.9,10?
The approval is based, in part, on trial results that demonstrated a clinically and statistically significant cure rate of 92.2% for patients with trichomoniasis treated with SOLOSEC? (n=64) as compared to placebo (p<0.001) (n=67) in the modified intent-to-treat population, patients who had trichomoniasis and no other STIs (94.9% in the Per-Protocol population) in the landmark Phase 3 clinical trial. SOLOSEC? was generally well-tolerated. No serious adverse events were observed in the trial, and the most commonly reported adverse events were vulvovaginal candidiasis (2.7%) and nausea (2.7%). The data were recently published in Clinical Infectious Diseases in March 2021 and presented at the 2020 Infectious Diseases Society for Obstetrics & Gynecology (IDSOG) Virtual Annual Meeting.
SOLOSEC? is now available for both treatment of patients and their partners.11?The FDA approval of SOLOSEC? for the treatment of trichomoniasis in men was granted based on four open-label trials in males; one comparative study with metronidazole and ornidazole in males only and three single-arm studies in males and females.11?Parasitological evaluation was performed both pre- and post-treatment and reported cure rates ranging from 91.7% (165/180) to 100% (30/30) at time points ranging from two to 20 days (n=437, 211 males and 226 females).11
?Trichomoniasis is a highly prevalent STI that can increase an individual?s risk for contracting or spreading other STIs, including human immunodeficiency virus (HIV). For approximately 70% of patients, trichomoniasis infection is asymptomatic.?12,13,14?If left untreated, trichomoniasis can persist for months or years14?and result in adverse reproductive health outcomes, including infertility and preterm birth,3??said Steven Chavoustie, M.D., FACOG, CCRP, Obstetrician and Gynecologist, Segal Institute for Clinical Research. He also stated, ?For these reasons, screening and treatment for trichomoniasis is crucial and I am pleased that there is a new treatment option available to help meet the needs of this patient population.?
Since trichomoniasis is a sexually transmitted disease, sexual partners should be treated with the same dose and at the same time, to prevent reinfection. Prescribers may consider presumptively treating partners by expedited partner therapy (EPT) where allowed by law.
About Trichomoniasis
Trichomoniasis is the most common non-viral, curable sexually transmitted infection (STI) in the U.S., and is caused by a protozoan parasite called Trichomonas Vaginalis (T. vaginalis).12?An estimated three to five million people have the infection every year.1
Trichomoniasis is four-to-five times more prevalent in women compared to men.15?However, 72% of male partners of women with trichomoniasis were also infected and 77% of those males were asymptomatic.16?Therefore, it is important for partners to be treated at the same time so that the infection is not passed back and forth. Signs and symptoms in women can include itching, burning, redness or soreness of the genitals, discomfort with urination and vaginal discharge.12
According to the CDC, diagnostic testing for trichomoniasis should be performed in women seeking care for vaginal discharge.14?Patients receiving care in high-prevalence settings (e.g., sexually transmitted disease clinics) and asymptomatic patients at high risk for infection (e.g., persons with multiple sex partners, history of sexually transmitted diseases/infections) may also be considered for screening.14?At-risk women with trichomoniasis have an increased risk for PID and a 2.6 times increased risk for persistent endometritis.8?Women who are pregnant with inadequately treated trichomoniasis are at an increased risk for pregnancy complications such as pre-term birth, premature rupture of membranes, or chorioamnionitis.17, 18, 19
Up to 53% of women with HIV infection also have?T. vaginalis, which is associated with an increased risk of contracting PID..14?Routine screening of asymptomatic women with HIV infection for?T. vaginalis?is recommended because of the adverse events associated with asymptomatic trichomoniasis and HIV infection.14
About Bacterial Vaginosis
Bacterial vaginosis (BV) is an infection caused by an imbalance of bacteria naturally found in the vagina.20?Symptoms of BV include an unpleasant or fishy odor, discharge (thin, milky grayish-white), or excessive discharge, and sometimes itching, burning sensation or irritation.20,21?However, some women may have no symptoms.21?BV is the most common vaginal infection for women, affecting more than 21 million women in the U.S. each year.22
BV provides a high pH, contributing to a favorable environment allowing?T. vaginalis, the protozoan parasite that causes trichomoniasis, to grow.12,23?In the Longitudinal Study of Vaginal Flora, women who presented for routine health visits and were diagnosed with BV were 1.5 to two times more likely to develop trichomonal, gonococcal and/or chlamydial infections.23?Trichomoniasis and BV can increase risks for pelvic inflammatory disease (PID),6,7,8?acquisition of STIs (gonorrhea, chlamydia, human papillomavirus (HPV) and herpes simplex virus (HSV),?9,10?and acquisition or transmission of human immunodeficiency virus (HIV).10
SOLOSEC? is recommended by the American College of Obstetricians and Gynecologists (ACOG) and the CDC for the treatment of BV.1, 24
About SOLOSEC?
SOLOSEC? (secnidazole) 2 g oral granules is the first and only single-dose oral prescription approved to treat both bacterial vaginosis (BV), a common vaginal infection, in adult women and trichomoniasis, a sexually transmitted infection, in adults.11?SOLOSEC? is designed to be easy to take and one oral dose contains a complete course of treatment.11,25?Additional information about SOLOSEC? can be found at?www.SOLOSEC.com.
INDICATION
SOLOSEC? (secnidazole) 2 g oral granules is an antimicrobial agent indicated for the treatment of bacterial vaginosis in adult women and trichomoniasis in adults. Since trichomoniasis is a sexually transmitted disease, treat sexual partners of infected patients with the same dose and at the same time to prevent reinfection.
DOSAGE AND ADMINISTRATION
SOLOSEC? is a single-dose therapy for oral use. The entire contents of SOLOSEC? packet should be sprinkled onto applesauce, yogurt or pudding and consumed once within 30 minutes without chewing or crunching the granules. SOLOSEC? is not intended to be dissolved in any liquid. Avoid consumption of alcoholic beverages and preparations containing ethanol or propylene glycol during treatment with SOLOSEC? and for at least 2 days after completing therapy.
IMPORTANT SAFETY INFORMATION
- SOLOSEC? is contraindicated in patients with a history of hypersensitivity to secnidazole or other nitroimidazole derivatives.
- Vulvovaginal candidiasis may develop with SOLOSEC? and require treatment with an antifungal agent.
- Potential risk of carcinogenicity is unknown and has not been studied in patients. Carcinogenicity has been seen in rodents chronically treated with nitroimidazole derivatives, which are structurally related to secnidazole. Chronic use should be avoided.
- Breastfeeding is not recommended. Patients should discontinue breastfeeding for 96 hours after administration of SOLOSEC?.
- Most common adverse reactions observed in clinical trials (incidence =2%) were vulvovaginal candidiasis, headache, nausea, dysgeusia, vomiting, diarrhea, abdominal pain, and vulvovaginal pruritus.